Cleared Traditional

K012909 - XTERRA GT POWER WHEELCHAIR

K012909 is an FDA 510(k) clearance for XTERRA GT POWER WHEELCHAIR, manufactured by Invacare Corp.. The device is a Class 2 Physical Medicine device with product code ITI cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K012909 · Invacare Corp. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2001
Decision
55d
Days
Class 2
Risk

K012909 is an FDA 510(k) clearance for the XTERRA GT POWER WHEELCHAIR. Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Invacare Corp. (Elyria, US). The FDA issued a Cleared decision on October 24, 2001 after a review of 55 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3860 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Invacare Corp. devices

FDA 510(k) Submission Details - K012909

510(k) Number K012909 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2001
Decision Date October 24, 2001
Days to Decision 55 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 115d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ITI Device Classification - Class 2, Special Controls

Product Code ITI Wheelchair, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3860
Definition A Powered Wheelchair Is A Battery-operated Device With Wheels That Is Intended For Medical Purposes To Provide Mobility To Persons Restricted To A Sitting Position. Fda Interprets “mobility To Persons Restricted To A Sitting Position” To Mean The Device Type Is Intended To Provide Mobility To Individuals Who Have Mobility Impairments And Require An Assistive Device For Mobility. Note: This Type Of Device Is Not Intended To Climb Stairs (see Product Code: Imk).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.

Regulatory Peers - ITI Wheelchair, Powered

All 220
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K012909.
STORM TDX POWER WHEELCHAIR
K023589 · Invacare Corp. · Nov 2002
INVACARE POWERED WHEELCHAIRS, MODELS M50, M51, M71 & M91
K021680 · Invacare Corp. · Jun 2002
INVACARE ELEVATING SEAT OPTION ESS6
K013516 · Invacare Corp. · Dec 2001
M71 POWER WHEELCHAIR
K012927 · Invacare Corp. · Sep 2001
MCC-MIV ONE 2 ONE SOFTWARE
K010364 · Invacare Corp. · Mar 2001
RANGER II M6, MODEL IN-888WNL
K002157 · Invacare Corp. · Aug 2000